AbbVie Launches Phase 3 Trial for Rheumatoid Arthritis

AbbVie Launches Phase 3 Trial for Rheumatoid Arthritis

AbbVie announced the start of a robust Phase 3 clinical trial to analyze the use of ABT-494 – an investigational oral selective JAK1 inhibitor – in the treatment of rheumatoid arthritis (RA). The trial will enroll adults who have never taken methotrexate and patients with inadequate responses to conventional disease-modifying anti-rheumatic drugs (DMARDs).

“We continue to leverage our expertise in rheumatology and immunology to address the unmet needs of patients living with immune-mediated diseases, including those who fail to respond to the current standard of care,” AbbVie Vice President of Pharmaceutical Development Scott Brun, M.D., said in a press release. “We are optimistic that our robust Phase 3 clinical trial program, which dosed the first patient in December, will help us further understand the therapeutic potential of ABT-494 across multiple patient populations and achieve our goal of providing patients with best-in-class treatment options.”

Phase 2 ABT-494 clinical trials, BALANCE-1 and BALANCE-2, demonstrated the efficacy of ABT-494 across 6 mg, 12 mg, and 18 mg doses twice a day, and 24 mg doses once-daily in patients with RA who had reported an inadequate response to prior anti-tumor necrosis factor (TNF-IR) or to methotrexate (MTX-IR) treatment.

One of the five Phase 3 trials included in the program, the SELECT-COMPARE clinical trial is a double-blind, placebo- and active-controlled study designed to evaluate the safety and efficacy of ABT-494 in combination with MTX in adults with moderate-to-severe RA who have experienced an inadequate response to prior treatment with MTX.

The first trial is scheduled for 48 weeks with a target number of 1,500 patients and, together with the second Phase 3 trial (SELECT-NEXT), is now open for enrollment in the U.S. All studies will evaluate the safety, tolerability and efficacy of ABT-494, including American College of Rheumatology (ACR) improvement criteria and levels of disease activity.

The three remaining Phase 3 trials will soon begin enrolling participants who have an inadequate response to biologics and those who have never taken MTX.

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